with applicable regulatory guidelines, such as FDA, ICH, and other relevant authorities, for photostability testing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that photostability testing is conducted according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Photostability Test Setup

1. The photostability test should be performed using a chamber or setup designed to simulate light exposure conditions. This can be a photostability chamber or a natural light environment with controlled exposure.
2. The light exposure should mimic the conditions that the product might encounter during transportation, storage, or use. The test should include both UV light (simulating sunlight exposure) and visible light.
3. The test should be conducted at the temperature and humidity conditions appropriate for the product type (typically 25°C ± 2°C and 60% ± 5% RH), or as per specific regulatory guidelines.
4. Samples should be placed in the chamber for a specified time period, typically ranging from 24 to 72 hours, depending on the product’s intended shelf life and regulatory requirements. The time period should be determined based on the product’s formulation and expected exposure to light during storage or use.

5.2. Selection of Test Samples

1. Representative samples of the aerosol formulation, including the final product and its packaging, should be selected for the photostability test. These samples should be labeled with the batch number, production date, and other relevant identifiers.
2. Samples should be selected from different batches to ensure that the photostability results are representative of the entire production lot.
3. The selected samples should include both unexposed and light-exposed samples to compare any changes in the product under different conditions.

5.3. Monitoring and Analyzing Test Results

1. During the photostability testing, the following parameters should be monitored and recorded:
   • Light intensity and type (UV and visible light) used during exposure
   • Duration of exposure
   • Temperature and humidity within the test chamber
2. After the exposure period, the aerosol samples should be evaluated for any changes in the following characteristics:
   • Appearance (e.g., color, clarity, can integrity)
   • Performance (e.g., spray rate, actuator functionality)
   • Chemical composition (e.g., propellant concentration, formulation stability)
   • Physical properties (e.g., viscosity, pH if applicable)
3. Data from the light-exposed samples should be compared with the control samples (samples not exposed to light) to identify any significant changes in product quality.
4. The test results should be documented in the Photostability Testing Results Log (Annexure-1).

5.4. Documentation and Record Keeping

1. All data generated from the photostability study should be documented accurately. Records should include:
   • Photostability Testing Results Log (Annexure-1)
   • Calibration records for light exposure equipment (if applicable) (Annexure-2)
   • Deviation records, including corrective actions taken (if applicable) (Annexure-3)
2. The results should be signed and dated by the responsible personnel, and all records should be stored securely for future reference and regulatory audits.
3. Photostability testing records should be retained for a minimum of 3 years or as required by regulatory guidelines.

5.5. Reporting of Photostability Test Results

1. The final photostability test report should be prepared, including all observed data, analysis results, and conclusions about the stability of the aerosol product under light exposure.
2. The report should include recommendations for packaging materials, shelf life, and storage conditions based on the findings of the photostability test.
3. The photostability report should be reviewed and approved by the QA team and relevant departments (e.g., Regulatory Affairs, Production). Once finalized, it should be stored in the company’s records for regulatory compliance and future reference.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity
• CFR: Code of Federal Regulations
• UV: Ultraviolet

7. Documents

1. Photostability Testing Results Log (Annexure-1)
2. Calibration Log for Light Exposure Equipment (Annexure-2)
3. Deviation Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Photostability Testing Results Log

Batch Number	Test Date	Light Exposure Time	Temperature	Humidity	Test Results	Operator Name
Batch-001	10/02/2025	48 hours	25°C	60%	Pass	Rajesh Patel

Annexure-2: Calibration Log for Light Exposure Equipment

Equipment ID	Calibration Date	Next Calibration Due	Operator Name	Remarks
LE-001	01/02/2025	01/08/2025	Rajesh Patel	Calibrated and ready for use

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-54321	Light intensity deviation	Adjusted light source and recalibrated equipment	Rajesh Patel	Completed

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated photostability test procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures